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Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan (SAVE J-II study)

Research Project

Project/Area Number 19K09419
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 55060:Emergency medicine-related
Research InstitutionKagawa University

Principal Investigator

Kuroda Yasuhiro  香川大学, 医学部, 教授 (80234615)

Co-Investigator(Kenkyū-buntansha) 一二三 亨  聖路加国際大学, 聖路加国際病院, 副医長 (30383756)
坂本 哲也  帝京大学, 医学部, 教授 (40365979)
井上 明彦  香川大学, 医学部, 協力研究員 (60835247)
Project Period (FY) 2019-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2021: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2020: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2019: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Keywords院外心停止 / ECPR / 心肺蘇生 / 膜型人工肺
Outline of Research at the Start

院外心停止患者の転帰は不良であるが、体外式膜型人工肺を組み合わせた心肺蘇生法(ECPR)では、救命率、神経学的転帰の改善が期待されている。しかし、ECPR は相当量の医療資源を必要とする複雑な処置であり、施行可能な施設は限られる。これまで十分な研究はなく、ガイドラインにおいても明確な適応基準や管理方法は決まっていない。本研究は、院外心停止に対してECPRが施行された患者を対象としたレジストリを構築し、本邦での診療実態を明らかにする多施設共同研究である。過去に世界的にもないECPRに特化した大規模データで、ECPRの適応や転帰改善に寄与する因子、介入限界を検討することを目的とする。

Outline of Final Research Achievements

This is the retrospective large cohort study named SAVE-J II study to provide real-world data on ECPR in Japan including details of clinical data with approximately 2,000 patients. This study aimed to assess patient characteristics, outcomes, and complications of ECPR practice in patients with OHCA.
In this large cohort, data on the ECPR of 1644 patients with OHCA show that the proportion of favorable neurological outcomes at hospital discharge was 14.1% and survival rate at hospital discharge was 27.2%. Complications were observed during ECPR in 32.7% of patients, and the most common complication was bleeding, with the rates of cannulation site bleeding and other types of hemorrhage at 16.4% and 8.5%, respectively.

Academic Significance and Societal Importance of the Research Achievements

院外心停止患者の転帰改善、社会復帰率上昇への取り組みは重要課題である。体外式膜型人工肺を組み合わせた心肺蘇生法(ECPR)では、救命率、神経学的転帰の改善が期待されているが、ECPR は侵襲が大きく相当量の医療資源を必要とするため施行可能な施設は限られる。ガイドラインにおいても明確な適応基準や管理方法は決まっておらず、また本邦における実態は不明である。本研究のようなECPRに特化した大規模なレジストリは世界的にもなく、ECPRに関連する十分な症例数のある研究は過去にない。世界的にもないECPRに特化した大規模データで、治療成績、適応、合併症を検討することの重要性は大きい。

Report

(4 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • Research Products

    (11 results)

All 2022 2021 2020 Other

All Journal Article (4 results) (of which Peer Reviewed: 4 results,  Open Access: 3 results) Presentation (6 results) (of which Int'l Joint Research: 1 results) Remarks (1 results)

  • [Journal Article] Details of Targeted Temperature Management Methods for Patients Who Had Out-of-Hospital Cardiac Arrest Receiving Extracorporeal Cardiopulmonary Resuscitation: A Questionnaire Survey2022

    • Author(s)
      Hifumi Toru、Inoue Akihiko、、Sakamoto Tetsuya、Kuroda Yasuhiro、on behalf of the SAVE-J II study group
    • Journal Title

      Therapeutic Hypothermia and Temperature Management

      Volume: - Issue: 4 Pages: 215-222

    • DOI

      10.1089/ther.2022.0004

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Extracorporeal cardiopulmonary resuscitation in adult patients with out-of-hospital cardiac arrest: a retrospective large cohort multicenter study in Japan2022

    • Author(s)
      Inoue Akihiko、Hifumi Toru、Sakamoto Tetsuya、Kuroda Yasuhiro、the SAVE-J II study group
    • Journal Title

      Critical Care

      Volume: 26 Issue: 1 Pages: 129-129

    • DOI

      10.1186/s13054-022-03998-y

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Variability of extracorporeal cardiopulmonary resuscitation practice in patients with out‐of‐hospital cardiac arrest from the emergency department to intensive care unit in Japan2021

    • Author(s)
      Hifumi Toru、Inoue Akihiko、Sakamoto Tetsuya、Kuroda Yasuhiro、SAVE‐J II Study Group
    • Journal Title

      Acute Medicine & Surgery

      Volume: 8 Issue: 1

    • DOI

      10.1002/ams2.647

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Extracorporeal Cardiopulmonary Resuscitation for Out‐of‐Hospital Cardiac Arrest in Adult Patients2020

    • Author(s)
      Inoue Akihiko、Hifumi Toru、Sakamoto Tetsuya、Kuroda Yasuhiro
    • Journal Title

      Journal of the American Heart Association

      Volume: 9 Issue: 7

    • DOI

      10.1161/jaha.119.015291

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] SAVE-J II study 結果2022

    • Author(s)
      井上明彦
    • Organizer
      第49回日本集中治療医学会学術集会
    • Related Report
      2021 Annual Research Report
  • [Presentation] ECPR for Out-of-hospital Cardiac Arrest Patients: A Retrospective Multicenter Study in Japan2022

    • Author(s)
      Akihiko Inoue
    • Organizer
      51st Critical Care Congress
    • Related Report
      2021 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 本邦における成人院外心停止に対するECPRの多施設後ろ向き観察研究(SAVE-J II study)2021

    • Author(s)
      井上明彦
    • Organizer
      第49回日本救急医学会総会・学術集会
    • Related Report
      2021 Annual Research Report
  • [Presentation] 本邦でのECPR・TTMの現状2021

    • Author(s)
      一二三亨
    • Organizer
      第48回日本集中治療医学会学術集会
    • Related Report
      2020 Research-status Report
  • [Presentation] Targeted Temperature Managementの 最前線-TTMの未来2020

    • Author(s)
      井上明彦
    • Organizer
      第48回 日本救急医学会総会・学術集会
    • Related Report
      2020 Research-status Report
  • [Presentation] 成人院外心停止に対するECPRの多施設後ろ向き観察研究(SAVE-J II study)2020

    • Author(s)
      井上明彦、一二三亨、坂本哲也、黒田泰弘
    • Organizer
      第47回日本集中治療医学会学術集会
    • Related Report
      2019 Research-status Report
  • [Remarks]

    • URL

      https://square.umin.ac.jp/save-j2/

    • Related Report
      2021 Annual Research Report

URL: 

Published: 2019-04-18   Modified: 2023-01-30  

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